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NCT00948311 Clinical Trial

Develop and Validate a Self-Administered Instrument That Will Screen for Eating Disorder Symptoms in Persons Aged 12 and Older With Type 1 Diabetes.

Type 1 Diabetes Clinical Trial

Official title:
Development of an Instrument to Screen for Eating Disorder Symptoms in Persons With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00948311
Other study ID # 03798-08-A
Secondary ID
Status Completed
Phase N/A
First received July 27, 2009
Last updated February 17, 2016
Start date December 2008
Est. completion date December 2015

Study information
Verified date February 2016
Source HealthPartners Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to develop and validate a survey instrument to be used by persons with type 1 diabetes aged 12 and older to screen for an eating disorder.

Description:

Phase 1 - Develop an initial instrument and start to establish content validity. What do dually diagnosed patients believe are the most important, relevant, and significantly contributing constructs that we should measure in order to capture those individuals with type 1 diabetes who may exhibit symptoms of an eating disorder? What individual items will best measure these constructs?

Phase 2 - Conduct individual interviews for cognitive testing of our instrument and further examine its content validity. How well do the individual items included in our instrument capture eating disorder symptoms in patients with type 1 diabetes? Do these items accurately capture the information we seek to collect? What symptoms have we not considered? How readable and understandable are our questions?

Phase 3 - Explore the internal consistency reliability and construct validity of our instrument. Do the items in our instrument accurately capture the constructs we wish to measure? Do similar items "hang together" in a manner that is clinically and theoretically meaningful?

Phase 4 - Address convergent and discriminant validity as well as test-retest reliability. Does our instrument demonstrate appropriate convergent and divergent validity as well as test-retest reliability? Does our instrument capture eating disorder symptoms among persons with diabetes? Is our instrument more specific to the population of individuals with diabetes than traditional eating disorder instruments (i.e., does our instrument capture more information and give a more accurate presentation than the other instruments)?

Recruitment information / eligibility
Status Completed
Enrollment 279
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility Inclusion Criteria:

- eating disorder

- type 1 diabetes

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States International Diabetes Center Minneapolis Minnesota

Sponsors (4)
Lead Sponsor Collaborator
HealthPartners Institute International Diabetes Center at Park Nicollet, Park Nicollet Eating Disorder Institute, Park Nicollet Foundation

Country where clinical trial is conducted

United States, 

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